Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

Just over a year ago, AstraZeneca went all in on creating a cell-therapy franchise; Samir Panjwani joined as a supplier-relationship manager. “I’ve been a builder throughout my career,” he says. The question he’s always kept in mind: Why are we in this industry? He discusses his new role, and his “bilateral experiences” supporting manufacturing outsourcing supply chains.

GUEST COLUMNISTS

Setting The Tone For A Fill/Finish Engagement Program
The initial 90 days of a fill/finish CDMO partnership establish lasting communication patterns, clarify mutual responsibilities, and test problem-solving capabilities critical to program success.
FDA's Guidance On Cell And Gene CMC Codifies Flexibility
The final guidance articulates common practices around validation, stability data, and reserve samples that, up until now, had been applied on a case-by-case basis.
Where Does 3D-Printed Single-Use Tech Fit In The Development Pipeline?
Additive manufacturing in early-phase process development is growing more common, but the practice comes with important considerations.
Emerging Technologies In Aseptic Processing: Hype Vs. Operational Reality
Let's debunk the misconception that robotics, gloveless systems, or fully closed isolators automatically result in Annex 1 compliance for cell and gene therapies.
Use Of AI In FDA Inspection Activities: Strategies For Effective Preparation
Are you ready? FDA has begun to implement the use of artificial intelligence in its operations, particularly during inspection activities.
A Comparison Of 6 Analytical Validation Guidelines Using Data Envelopment Analysis
This is the first published application of data envelopment analysis to six major pharmaceutical analytical validation guidelines, including ICH Q2(R2), USP, ChP, and Brazil's ANVISA.
Managing Organic Impurities And Nitrosamines In APIs
How API manufacturers can assess and mitigate organic impurities and nitrosamines using risk-based strategies aligned with global regulatory expectations.
AI Has Arrived In Biotech CMC Amid Patchwork Governance
AI is surfacing within regulatory and CMC workflows at a vigorous pace. Unfortunately, in small and midsize biotechs, it's happening faster than governance can keep up.

PHARMA OUTSOURCING WHITE PAPERS

Mastering Pharmaceutical Cleaning Validation Methods
View the basics of cleaning validation and discuss the support services you should seek from your critical cleaning products supplier to optimize your cleaning validation process.

Biomanufacturing Readiness: A Validation Model For Multiproduct Facilities
Optimize your validation strategy to meet evolving regulatory demands and product complexities with a scalable, efficient framework that accelerates facility readiness and ensures consistent quality.
Spray Dried Dispersions In Controlled Release Formulations
Integrating spray dried dispersions with CR strategies addresses poor drug solubility and the need for tailored release kinetics. Explore considerations to ensure stability and sustained supersaturation.
Science With Purpose: Advancing Sustainability In Biopharma Testing
Learn how biopharma labs are cutting animal use, energy, and paper waste while maintaining GMP compliance — with specific data on 85% labor reductions and 1 ton of CO2e saved annually.
International Reference Pricing (IRP): Foundations, Shifts, And What To Do Next
As global pricing reforms evolve and policies gain traction, stakeholders must critically reassess the role of International Reference Pricing in balancing affordability, access, and incentives for innovation.
Accelerating ADC Analytical Method Development Through Platform Innovation
Leverage a platform-based analytical development strategy to accelerate ADC IND readiness through early CQA identification, reduced development risk, and streamlined progression from development to patients.